Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT02919020
Status:
COMPLETED
Last Update Posted:
2021-07-22
First Post:
2016-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Proprioceptive Neuromuscular Facilitation in Older Women With Gonarthrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052580', 'term': 'Muscle Stretching Exercises'}, {'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-17', 'studyFirstSubmitDate': '2016-09-24', 'studyFirstSubmitQcDate': '2016-09-28', 'lastUpdatePostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain', 'timeFrame': '"change from baseline in pain 6th - 12th week"', 'description': '"Pain control diary"'}, {'measure': 'Quality of life', 'timeFrame': 'change from baseline in quality of life 6th-12th week', 'description': 'Western Ontario and McMaster Universities Questionaire'}, {'measure': 'Functional performance', 'timeFrame': 'Change based on functional performance 6th - 12th week', 'description': '"30 s -chair stand test"'}, {'measure': 'Quality of life', 'timeFrame': 'Change based on functional performance 6th - 12th week', 'description': 'Medical Outcomes Study 36 - Item Short - Form Health Survey'}, {'measure': 'Functional Performance', 'timeFrame': 'Change based on functional performance 6th - 12th week', 'description': '"Walk Test of 40 meters at a rapid pace'}, {'measure': 'Functional Performance', 'timeFrame': '"Walk Test of 40 meters at a rapid pace', 'description': '"Stair climb test"'}], 'secondaryOutcomes': [{'measure': 'pain sensitivity threshold', 'timeFrame': 'change from baseline in pain threshold 6th-12th week pressure', 'description': '"Algometry"'}, {'measure': 'Range of motion', 'timeFrame': '"change from baseline in the range of knee flexion 6th-12th week"', 'description': '"Universal Goniometer"'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Proprioceptive Neuromuscular Facilitation (PNF )', 'resistance exercise'], 'conditions': ['Osteoarthritis Knee']}, 'descriptionModule': {'briefSummary': 'To evaluate the effectiveness of the method Proprioceptive Neuromuscular Facilitation (PNF) as physical therapy approach to the reduction of pain and improvement in functional performance and quality of life in women with knee osteoarthritis.', 'detailedDescription': 'Patients will be divided into two groups: group perform proprioceptive neuromuscular facilitation and other group submit performing resistance exercises.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women;\n* Age between 50 and 80 years;\n* Clinical diagnosis of Osteoarthritis of knees ;\n* Patients with presence of at least 90 ° range of motion of knee flexion ;\n* Do not practitioners of physical exercise and physical therapy during the period of participation in the survey\n\nExclusion Criteria:\n\n* Diagnosis of other rheumatological and neurological diseases ;\n* orthopedic surgery History in the lower limbs ;\n* Individuals with muscle strength of the lower limbs \\<3 ;\n* Cognitive impairment or neurological disease that compromises the understanding and implementation of the Protocol (Mini Mental State Examination \\<18 for the illiterate and \\<24 for others);\n* Body mass index ≥ 30.0 (obesity , according to the World Health Organization ) .\n* Individuals classified as physical activity level "very active" by the IPAQ (International Physical Activity Questionnaire ) .'}, 'identificationModule': {'nctId': 'NCT02919020', 'acronym': 'PNF', 'briefTitle': 'Efficacy of Proprioceptive Neuromuscular Facilitation in Older Women With Gonarthrosis', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal de Pernambuco'}, 'officialTitle': 'Efficacy of Proprioceptive Neuromuscular Facilitation About Functional Performance, Pain and Quality of Life in Older Women With Gonarthrosis: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ECR2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proprioceptive neuromuscular facilitation (PNF);', 'description': 'Proprioceptive neuromuscular facilitation, using the technique of rhythmic initiation and Combination of Isotonic on lower members', 'interventionNames': ['Other: Proprioceptive neuromuscular facilitation (PNF)']}, {'type': 'EXPERIMENTAL', 'label': 'resistance exercise', 'description': 'Resistance exercise to strengthen lower limbs', 'interventionNames': ['Other: Resistance exercise']}], 'interventions': [{'name': 'Proprioceptive neuromuscular facilitation (PNF)', 'type': 'OTHER', 'description': 'Proprioceptive neuromuscular facilitation, using the technique of rhythmic initiation and Combination of Isotonic on lower members', 'armGroupLabels': ['Proprioceptive neuromuscular facilitation (PNF);']}, {'name': 'Resistance exercise', 'type': 'OTHER', 'description': 'resistance exercise to strengthen lower limbs', 'armGroupLabels': ['resistance exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50710430', 'city': 'Petrolina', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'Hospital Universitário Drº Washigton Antônio de Barros', 'geoPoint': {'lat': -9.39861, 'lon': -40.50083}}], 'overallOfficials': [{'name': 'Daniella A Oliveira', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidade Federal de Pernambuco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal de Pernambuco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Daniella Araújo de Oliveira', 'class': 'UNKNOWN'}, {'name': 'Angélica da Silva Tenório', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigador Principal', 'investigatorFullName': 'Thaís Ferreira Lopes Diniz Maia', 'investigatorAffiliation': 'Universidade Federal de Pernambuco'}}}}